Claims for Patent: 12,458,695

Summary for Patent: 12,458,695

Title:	Dosing regimens and related compositions and methods
Abstract:	In some aspects, the present invention provides cell-reactive compstatin analogs and compositions comprising cell-reactive compstatin analogs. In some aspects, the invention further provides methods of using cell-reactive compstatin analogs, e.g., treat a complement-mediated disorder, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ. In some aspects, the invention provides long-acting compstatin analogs and compositions comprising long-acting compstatin analogs. In some aspects, the invention further provides methods of using long-acting compstatin analogs, e.g., to treat a complement-mediated disorder, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ. In some aspects, the invention provides targeted compstatin analogs and compositions comprising targeted compstatin analogs. In some aspects, the invention further provides methods of using targeted compstatin analogs, e.g., to treat a complement-mediated disorder, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ.
Inventor(s):	Federico Grossi, Pascal Deschatelets, Cedric Francois, Patrick Johnson, Carolina Vega
Assignee:	Apellis Pharmaceuticals Inc
Application Number:	US19/054,696
Patent Claims:	1. A composition comprising: (i) a long-acting compstatin analog (LACA) having a structure: wherein the (CH2CH2O)n moiety has an average molecular weight of about 40,000 Daltons; (ii) a pharmaceutically acceptable carrier; and (iii) trehalose, wherein the pH of the composition is 4.9 to 5.1. 2. The composition of claim 1, wherein the LACA is at a concentration of about 150 mg/mL. 3. The composition of claim 2, wherein the composition has an osmolality between 180 mOsm/kg and 500 mOsm/kg. 4. The composition of claim 3, wherein the composition comprises an acetate buffer. 5. The composition of claim 4, wherein the acetate buffer comprises sodium acetate and acetic acid. 6. The composition of claim 5, wherein the pharmaceutically acceptable carrier is water. 7. The composition of claim 6, wherein the pH of the composition is 5.0. 8. A single dose vial containing the composition of claim 6 for delivery of a 100 microliter dose of said composition. 9. The composition of claim 2, wherein the composition has an osmolality between 200 mOsm/kg and 400 mOsm/kg. 10. The composition of claim 9, wherein the composition comprises an acetate buffer. 11. The composition of claim 10, wherein the acetate buffer comprises sodium acetate and acetic acid. 12. The composition of claim 1, wherein the pharmaceutically acceptable carrier is water. 13. The composition of claim 1, consisting essentially of the LACA, trehalose, acetate buffer, and water. 14. The composition of claim 13, wherein the acetate buffer comprises sodium acetate and acetic acid. 15. The composition of claim 13, wherein the LACA is at a concentration of about 150 mg/mL and the composition has an osmolality between 180 mOsm/kg and 500 mOsm/kg. 16. The composition of claim 15, wherein the pH of the composition is 5.0. 17. A single dose vial containing the composition of claim 15, for delivery of a 100 microliter dose of said composition. 18. The composition of claim 15, wherein the LACA is at a concentration of about 150 mg/mL and the composition has an osmolality between 200 mOsm/kg and 400 mOsm/kg. 19. A composition comprising: (i) a long-acting compstatin analog (LACA) having a structure: wherein the (CH2CH2O)n moiety has an average molecular weight of about 40,000 Daltons; (ii) a pharmaceutically acceptable carrier; and (iii) trehalose, wherein the pH of the composition is 4.5 to 5.0. 20. The composition of claim 19, wherein the LACA is at a concentration of about 150 mg/mL. 21. The composition of claim 20, wherein the composition has an osmolality between 180 mOsm/kg and 500 mOsm/kg. 22. The composition of claim 21, wherein the composition comprises an acetate buffer. 23. The composition of claim 20, wherein the composition has an osmolality between 200 mOsm/kg and 400 mOsm/kg. 24. The composition of claim 23, wherein the composition comprises an acetate buffer. 25. The composition of claim 24, wherein the pharmaceutically acceptable carrier is water. 26. The composition of claim 19, consisting essentially of the LACA, trehalose, acetate buffer, and water. 27. The composition of claim 26, wherein the acetate buffer comprises sodium acetate and acetic acid. 28. The composition of claim 26, wherein the LACA is at a concentration of about 150 mg/mL and the composition has an osmolality between 180 mOsm/kg and 500 mOsm/kg. 29. A single dose vial containing the composition of claim 28, for delivery of a 100 microliter dose of said composition. 30. The composition of claim 19, wherein the pH of the composition is 4.5.